Strides receives USFDA approval for Amantadine Hydrochloride tablets and capsules

27 Feb 2022 , 01:34 AM

Strides Pharma Science today announced that its step-down wholly owned subsidiary Strides Pharma Global Singapore has received approval for Amantadine Hydrochloride Softgel Capsules USP100 mg from the United States Food Drug Administration USFDA The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug RLD Symmetrel Capsules 100 mg of Endo Pharmaceuticals Inc Endo According to IQVIA MAT December 2021 data the US market for Amantadine Hydrochloride Capsules USP100 mg is approximately US$ 11 Mn The product will be manufactured at the companys facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market The company also has approval for Amantadine Hydrochloride tablets and the combined market size of Tablets and Capsules together is approximately US$ 21 Mn as per IQVIA MAT December 2021 data